Phase 2 trial of Axitinib and TRC105 versus Axitinib alone
Research type
Research Study
Full title
A Randomized Phase 2 Trial Of Axitinib and TRC105 Versus Axitinib Alone (Including A Lead-In Phase 1b Dose-Escalation Portion) In Patients With Advanced Or Metastatic Renal Cell Carcinoma
IRAS ID
191115
Contact name
Robert Hawkins
Contact email
Sponsor organisation
TRACON Pharmaceuticals, Inc.
Eudract number
2015-003436-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 17 days
Research summary
The purpose of this research study is to compare the effectiveness of a combination therapy of the investigational drug, TRC105 with axitinib versus axitinib alone. Axitinib is an approved therapy in patients with advanced or metastatic renal cell carcinoma.
New blood vessel formation on the tumour site leads to tumour growth and cancer progression. The inhibition of this process represents a potentially effective strategy for the prevention and treatment of solid cancers. TRC105 is a monoclonal antibody that is made in a laboratory, which can locate and attach to certain cells in the body such as growing tumour blood vessels, and thus prevent the growth of new tumour vessels.
Approximately 150 patients with advanced or metastatic renal cell carcinoma will be enrolled in the phase 2 portion of the study. Patients at screening must meet the eligibility requirements.
Participants will be randomly assigned to one of the two treatment groups in a 1:1 ratio. Arm A will involve axitinib therapy alone, while Arm B will involve axitinib plus TRC105 therapy. All patients will initially receive axitinib 5 mg twice daily and patients randomised to receive TRC105 will take TRC105 at 3 mg/kg on day 1, 7 mg/kg on day 4, and 10 mg/kg on day 8 and weekly thereafter.
TRC105 may also be administered every two weeks on days 1 and 15 starting with cycle 2 day 1 at either 15 mg/kg or 20 mg/kg based on the results obtained from Phase 1B study.Participants will continue on treatment until disease progression, unacceptable toxicity or withdrawal of consent . The participants will continue to receive follow-up care for approximately 28 days after they stop receiving the TRC105 study drug or axitinib.
The study is being sponsored by Tracon Pharmaceuticals Inc.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0162
Date of REC Opinion
14 Jun 2016
REC opinion
Further Information Favourable Opinion